Sr. Manager/Associate Director, CMC Development

Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at our South San Francisco office.

As a crucial member of our team, reporting directly to the Head of CMC, you'll play an integral role in advancing our small molecule pipeline. Your responsibilities will include driving the development and manufacturing of drug substances, overseeing both internal and external resources, and collaborating closely with CDMOs to ensure the successful progression of our innovative compounds.

Frontier Medicines offers a dynamic environment with the opportunity to impact the lives of patients while conducting cutting-edge science.  There are short communication lines across the company, and we encourage and support the professional development of our team members. This individual will play an essential role in Frontier’s to support both the Boston and the South San Francisco offices.

What will you be doing?

• Managing daily pre-formulation/material assessments of API and preclinical formulations
• Fostering collaboration with CMC and Discovery R&D teams
• Conducting development studies, interpreting results, and suggesting follow-up actions independently
• Overseeing drug substance process development and manufacturing
• Coordinating drug substance program management
• Engaging with CROs/CDMOs and identifying new technologies
• Ensuring comparability assessments and cultivating vendor relationships
• Supervising third-party activities and delivering project updates with recommendations

Traits we believe make a strong candidate:

• PhD. in Pharmaceutical Chemistry, Materials Science, Medicinal Chemistry with 5+ years, MSc. with 8+ years, or BS with 10+ years of experience in small molecule drug substances and drug products
• Project Management experience considered advantageous
• Proven ability to work independently, multitask effectively, and manage a diverse range of projects simultaneously.
• Experience with quality by design (QbD), process validations and statistical design of experiments (DOE) is preferred
• Experience with early through late-stage process development is strongly preferred
• Team player who will be able to collaborate effectively in a cross-functional matrix team environment including Safety Assessment and DMPK groups
• Exceptional oral communication and writing skills
• A thorough understanding of ICH guidelines, GLP/GMP manufacturing, and related regulatory requirements is required
• Ability to travel domestically and/or internationally to achieve goals, when required